Trial · NCT02291783
Phase I, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of an M1 Agonist to Treat Cognitive Impairment
NCT02291783, Phase 1, Completed, Nxera Pharma UK Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of an M1 Agonist to Treat Cognitive Impairment. Trials, record NCT02291783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02291783
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of an M1 Agonist to Treat Cognitive Impairment
- NCT number
- NCT02291783
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 108 participants, actual
- Lead sponsor
- Nxera Pharma UK Limited
- Conditions
- Alzheimer's Disease
- Interventions
- HTL0009936, HTL0009936 placebo
- First posted
- 2014-11-14
- Last updated
- 2017-06-20
- Other registries' IDs
- eudract:2013-002307-34
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with Adverse Events, as a measure of safety and tolerability | From signing of informed consent up to 30 days after the final visit | AE reports include a description of the AE, date and time of onset and resolution, intensity, and relationship to IMP. |
| Primary | Changes in Safety Lab parameters as a measure of safety and tolerability | Screening, Day-1, at select dosing days, and at 5 to 7 days post dose for single doseand 15 to 17 days post first dose in multiple dosing. | Hematology, clinical chemistry, urinalysis |
| Primary | Changes in vital signs as a measure of safety and tolerability | Screening, Day-1, at select dosing days and at 5 to 7 days post dose for single dose, and 15 to 17 days post first dose in multiple dosing. | Pulse rate,body temperature,blood pressure, and orthostatic changes. |
| Primary | Changes in 12-lead electrocardiograms as a measure of safety and tolerability | Screening, pre-dose, at select dosing days and at 5 to 7 days post dose for single dose,and 15 to 17 days post first dose in multiple dosing. | Change in ECG parameters |
| Secondary | Pharmacokinetic measures in plasma as measured by Peak plasma concentration (Cmax) | Pre-dose, multiple time points to 24h, at select dosing days, and 5 to 7 days post dosefor single dose,and 15 to 17 days post first dose in multiple dosing. | Peak plasma concentration (Cmax), time at occurrence of Cmax (tmax), Area under the plasma concentration versus time curve (AUC) 0-t, 0- infinity, percent of AUC 0-infinity, Cmax normalized by dose, AUC 0-t normalized for dose. |
| Secondary | Pharmacokinetic measures in cerebro spinal fluid (CSF) in young males as measured by max observed CSF (Cmax CSF) | Part 1 - 1h, 2h,3h post dose | Maximum observed CSF concentration (Cmax CSF), area under the CSF concentration versus time |
| Secondary | Pharmacokinetic measures to assess the food effect as measured by ANOVA | Pre-dose, multiple time points to 24h, and at 12h, 24h and 5 to 7 days post dose. | Food effect analysis will be based on analysis of variance (ANOVA) for treatment differences. |
| Secondary | Pharmacodynamic response as measured by pupillometry | Multiple time points Day1 to 6h post dose Part 1 only. | Changes in average pupil diameter as measured in 3 different conditions of lux. |
| Secondary | Pharmacokinetic measures in urine in young males and elderly male and female subjects as measured by amount of urine excreted at collection intervals | Pre-dose,multiple 4h collection intervals to 24h post dose on select dosing days to Day 10 for multiple dosing. | Amount excreted in urine at each collection interval (Ae1-t2) all parts. Cumulative amount excreted to 12h and 24h (Ae0-t) depending on Part. Cumulative urine excreted of unchanged drug to 24h (Fe%) and to 12h depending on Part. Volume of urine collected during each collection interval (Vur), and renal clearance (CLr) all parts |
| Secondary | Pharmacodynamic response as measured by Bond and Lader visual analogue scale | Day 1 at multiple timepoints to 24h post dose. | Changes in 3 factor scores (Alertness, Contentedness and Calmness) which will be derived from the individual VAS scores |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02291783
GET https://conductscience.org/api/trials/v1/NCT02291783/registered